Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure.

BACKGROUND We hypothesized that the total face mask (TFM) would be perceived as more comfortable than a standard oronasal mask (ONM) by patients receiving noninvasive mechanical ventilation (NIV) therapy for acute respiratory failure (ARF) and would be quicker to apply by respiratory therapists. METHODS Sixty patients presenting with ARF were randomized to receive NIV via either an ONM or a TFM. Mask comfort and dyspnea were assessed using visual analog scores. Other outcomes included time required to apply, vital signs and gas exchange at set time points, and early NIV discontinuation rates (ie, stoppage while still requiring ventilatory assistance). RESULTS Mask comfort and dyspnea scores were similar for both groups through 3 h of use. The time required to apply the mask (5 min [interquartile range (IQR), 2-8] vs 3.5 min [IQR, 1.9-5]), and duration of use (15.7 h [IQR, 4.0-49.8]) vs 6.05 h [IQR, 0.9-56.7]) were not significantly different between the ONM and the TFM group, respectively. Except for heart rate, which was higher at baseline in the TFM group, no differences in vital signs or gas exchange were detected between the groups during the first 3 h (P > .05). Early NIV discontinuation rates were similar for both the ONM group and TFM group (40% vs 57.1%); however, eight patients in the TFM group were switched to an ONM within 3 h, and none from the ONM group was switched to a TFM (P < .05). CONCLUSIONS Among patients with ARF requiring NIV, the ONM and TFM were perceived to be equally comfortable and had similar application times. Early NIV discontinuation rates, improvements in vital signs and gas exchange, and intubation and mortality rates were also similar. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT00686257; URL: www.clinicaltrials.gov.